# K011097: Quickvue Dipstick Strep a

- Pathway: 510(k) (Traditional)
- Applicant: Quidel Corp.
- Decided: May 8, 2001 after 27 days
- Product code: GTY (Antigens, All Groups, Streptococcus Spp.)
- Device class: 1
- Regulation: 21 CFR 866.3740
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K123793: Sofia Strep a Fia (2013), 2 descendants of its own
- K141775: Sofia (R) Strep a+ Fia (2014), 1 descendant of its own
- K171976: Sofia Strep A+ FIA, Sofia 2 Analyzer (2017), 0 descendants of its own

## Recalls of this device
- Apr 6, 2026 · Class II · Z-2169-2026: Product has the potential for false positive results
- Jun 17, 2025 · Class II · Z-2545-2025: Dipstick strep A test has potential for false positive results.

Source page: https://510kreport.com/device/K011097
Methodology: https://510kreport.com/methodology